Highly experienced attorneys representing clients before the Pharmacy Board.
As a pharmacy owner or pharmacist there are few things as stressful as receiving notice of an investigation or proposed disciplinary action from the Texas State Board of Pharmacy. Whether legitimate or not, Pharmacy Board complaints can pose a serious threat to your business or employment opportunities. Even complaints that have little chance of leading to a license revocation or suspension can create long-lasting damage to your pharmacy or career.
The attorneys at Lype, Dest & Smith Lawyers have defended hundreds of pharmacies and pharmacists in investigations and disciplinary actions before the Texas State Board of Pharmacy. This experience covers all different types of Board complaints both common and uncommon. We have represented clients at every possible stage of a Pharmacy Board case from initial investigations, to informal conferences, contested case hearings, and appeals of Board Orders all the way to the Supreme Court of Texas. This background means our attorneys don’t need to spend hours researching Texas pharmacy law or Board procedure. Most importantly, our hard-won experience has given us an understanding of what does and does not work when defending clients before the Board.
The Texas State Board of Pharmacy pursues complaints aggressively and issues a large number of disciplinary orders against pharmacies and pharmacists every year. It has a multi-million-dollar annual budget and enforcement and legal department staffed with their own dedicated attorneys and investigators. The Board’s disciplinary and procedural statutes and rules are extensive and often difficult to understand.
Seeking the advice and possible representation of an attorney who understands the Pharmacy Board and their process is crucial to achieving a good outcome. Based on our long history with the Pharmacy Board, our attorneys can review the facts of your case and accurately assess the potential risks and range of results. Our experience also allows our attorneys to help craft an effective defense and best position a client for a good outcome. Just like a pharmacist is trained to provide clear and accurate information concerning medications, the attorneys at Lype, Dest & Smith have the training and experience to effectively defend clients before the Pharmacy Board.
“Your legal challenges deserve precise attention and dedicated advocacy. We’re committed to navigating the complexities of law, ensuring your rights are safeguarded and your objectives achieved. Trust our experienced team to stand by you every step of the way.”
Dan Lype
Founding Attorney
Our attorneys have represented pharmacy and pharmacist clients in cases involving all different types of complaints. Some of the most common grounds for Pharmacy Board complaints include alleged:
Most complaints before the Texas State Board of Pharmacy originate from a patient, family member, employer, competitor, or law enforcement. The Board also opens investigations on its own following a Board inspection or internal review of a pharmacy’s Prescription Monitoring Program data. Other investigations are generated following events that require mandatory reporting to the Board, such as the loss or theft of controlled substances.
Unlike other Texas professional licensing boards, the Texas State Board of Pharmacy does not normally start a case by sending written notice to the pharmacy or pharmacist that they are under investigation. Instead, the pharmacy or pharmacist becomes aware they are under investigation when a Board investigator shows up at the pharmacy or even their home.
The Pharmacy Board’s investigators are certified peace officers with most having a prior background in law enforcement. They will ask the pharmacy’s staff questions and request records with a short response deadline. The Board investigator may also request written statements from the pharmacist-in-charge and other employees of the pharmacy .
If the Pharmacy Board’s enforcement departments determine a violation has likely occurred, they will notify the pharmacy or pharmacist in writing of the Board’s intention to take disciplinary action against their license. In most instances this notice also informs the pharmacy or pharmacist that they have been scheduled for an informal conference. In other cases, the licensee will be presented with a settlement proposal and given the option of either accepting the proposal, requesting an informal conference, or asking that their case be set for a contested case hearing.
If the case proceeds to an informal conference, the pharmacy owner, the pharmacist, and their attorney will appear before a Board Panel to discuss the case, answer questions, and try to reach an agreed resolution. Informal conferences are confidential, and since the COVID-19 pandemic have been exclusively held by videoconference. The Board Panel will consist of two Board members, the Board’s executive director and general counsel, and the Board attorney who has been assigned to the case. At the close of the informal conference, the Panel can move to dismiss the case or recommend that it be resolved through disciplinary or non-disciplinary action.
If an informal conference does not lead to a dismissal or settlement, the Board attorney will file a formal complaint and the case will be set for a contested case hearing at the State Office of Administrative Hearings. The State Office of Administrative Hearings is a separate state agency responsible for conducting trials and mediations involving Texas licensing agencies. A contested case hearing is a non-jury, bench trial before an administrative law judge. At the hearing, witnesses will provide sworn testimony and evidence will be admitted by the judge. The Pharmacy Board will be represented by a Board attorney who has extensive experience litigating these types of cases.
If both parties agree, a mediation can be held prior to trial. The mediation will be attended by a third-party mediator, the pharmacy or pharmacist and their attorney, and a Board member and Board attorney. Most mediations will involve a period of back-and-forth between the parties and mediator until an agreed resolution is reached. If the parties are unable to settle, the case will be reset for a trial.
After a trial, the administrative law judge will issue a detailed decision known as a Proposal for Decision. This contains factual and legal findings and states whether the Board has met their burden to prove one or more violations. If the Board has failed to prove a violation, the judge will recommend the case be dismissed. If the Board has established one or more violations, the administrative law judge will recommend a sanction to the Board.
The Board will consider the judge’s Proposal for Decision at a full Board meeting. The Board has the ability to accept the judge’s findings and recommendation as-is or, within certain bounds, disagree with the judge’s legal conclusions or recommended sanction. The Board will then enter a final Board Order resolving the case. If the pharmacy or pharmacist wants to challenge the Board’s Order, they must file an appeal –known as a petition for judicial review–within a strict time frame.
The attorneys at Lype, Dest & Smith have defended pharmacy and pharmacist clients before the Texas State Board of Pharmacy in all types of situations and cases. The following is a sampling of the type of cases our attorneys have handled.
The Pharmacy Board opened an investigation of an independent community pharmacy following an inspection. The Board’s review of the pharmacy’s dispensing records and Prescription Monitoring Program data indicated the pharmacy was not appropriately exercising its corresponding responsibility when dispensing controlled substances to chronic pain patients. After a comprehensive review and adjustment of the pharmacy’s practices and procedures when dispensing controlled substances, the Pharmacy Board dismissed the investigation with a non-disciplinary advisory letter.
A patient’s relative complained after an alleged dispensing error harmed her elderly father. The error was alleged to have been caused during a prescription transfer from another pharmacy. We produced evidence at an informal conference showing the medication was dispensed as ordered, however, the pharmacy failed to document the telephonic prescription. The client’s case was resolved with a reprimand and fine. Representation also included the pharmacist owner who dispensed the prescription. The pharmacist received a non-disciplinary Remedial Plan.
A large compounding pharmacy located in Texas had dispensed medications to multiple other states without having the required non-resident pharmacy permits. A complaint was filed with the Texas Pharmacy Board by the pharmacy board in one of the other states. After the presentation of remedial measures including appointment of a new director in charge of compliance outside of Texas, the Texas Pharmacy Board agreed to resolve the case with a small administrative penalty.
The Texas Pharmacy Board opened an investigation of a pharmacy following an FDA inspection that resulted in the issuance of a Form 483 and Warning Letter. The Pharmacy Board decided to close their investigation after being presented with evidence that the FDA Warning Letter was based on their application of regulations and CGMP that are not required under Texas law.
Large Texas compounding pharmacy issued a voluntary recall of certain medication lots following an FDA inspection and the issuance of a Form 483. The voluntary recall was based on the FDA’s concerns the pharmacy could not guarantee the sterility of medication. The Texas State Board of Pharmacy opened an investigation. After submitting evidence of the pharmacy’s remedial measures to address the FDA’s observations, theTexas Pharmacy Board closed the case with an informal warning letter.
The Texas Pharmacy Board proposed to indefinitely suspend a pharmacist’s license based on the suspension of their license in another state for substance use issues. The client’s case was taken to trial. The judge issued a favorable decision recommending that the pharmacist’s be placed on probation without any suspension. The Board rejected the judge’s recommendation and suspended the pharmacy’s license anyway. The client’s case was then successfully appealed with the Pharmacy Board entering an order unsuspending the client’s license after oral argument before the Texas Supreme court.
The Texas Pharmacy Board moved to temporarily suspend a pharmacist’s license based on their alleged dispensing of non-therapeutic prescriptions for opioids, benzodiazepines, and other controlled substances. After the presentation of evidence and testimony at a temporary suspension hearing, the Board Panel voted to not temporarily suspend the pharmacist’s license.
The Pharmacist-in-charge at a big-box pharmacy was investigated following unexplained shortages of controlled substances. The pharmacist’s defense included showing that their employer’s corporate policy involved intentionally withholding loss prevention tools from its pharmacists-in-charge. The phamacist’s case was resolved through a Board Order requiring the client to complete six additional hours of continuing education.
A pharmacist inadvertently administered an undiluted dose of a vaccine to several pediatric patients. After the presentation of mitigating factors and remedial measures taken by the pharmacist, the Board agreed to resolve the case through an Order requiring the pharmacist take six extra hours of continuing education.
The Texas Pharmacy Board investigating a pharmacist for accessing a relative’s Texas Prescription Monitoring Program without authorization. We presented evidence demonstrating the pharmacist’s motivation was to protect their parent who was potentially at risk due to the relative’s substance abuse. The Board agreed to settle the case with a minor administrative fine.
A pharmacist at a big-box pharmacy was alleged to have been involved in a dispensing error that caused pediatric patients to mistakenly receive each other’s compounded medication. The pharmacist’s defense involved showing systems issues at the pharmacy that were outside the client’s control plus evidence of her implementation of new procedures following the error. The Board agreed to resolve the pharmacist’s case with a disciplinary order that included no requirements or restrictions.
If you are a pharmacy owner or pharmacist and are facing a Texas State Board of Pharmacy investigation or potential disciplinary action, contact the attorneys at Lype, Dest & Smith today for a consultation. Our attorneys are highly experienced representing clients before the Pharmacy Board and know which defenses work and which do not. Facing the Pharmacy Board alone is both risky and unnecessary. Early intervention by knowledgeable legal counsel is crucial and often the difference maker between an easy resolution and a damaging Board order.
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A thorough and experienced lawyer. We are grateful to have Dan and his staff helped us with our case, dealing with Texas Medical Board. Dan is honest, experienced and very thorough. He was supportive throughout the proceedings. His caring and calm nature has made us feel at ease during the whole process. His office staff was professional and responsive. Dan responded to our phone calls and emails promptly. We wholeheartedly recommend Dan and his firm without any reservation.
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